Adverse events following immunisation (AEFI) must be managed and reported.

What is an adverse event following immunisation (AEFI)?

Vaccines, like any medication or natural therapy, can have side effects. An AEFI is any negative reaction that follows immunisation.

It can be either expected or unexpected, and may not be triggered by the vaccine or only coincidentally occurs after getting a vaccine.

When to report AEFIs

Most reactions to vaccines are like a low grade fever and pain at the spot where the needle went in. They are mild and usually only last a little while. These reactions do not require special treatment or reporting. You should report to the state and territory AEFI contacts below if you have concerns about a reaction that:

On very rare occasions, a severe allergic reaction may occur. Anaphylaxis is the most severe form of allergic reaction and is life threatening if it is not treated immediately. Anaphylaxis is an allergic reaction involving more than one body system, for example skin, respiratory, gastro-intestinal and cardiovascular systems.

Why report an AEFI

By providing all information relevant to a specific adverse event, you can help TGA to assess the possible role of the product in causing the adverse event.

Consumer reporting

Consumers wanting to report a side effect to a vaccine by telephone are encouraged to speak to a pharmacist from NPS Medicinewise on 1300 134 237. The pharmacist can both lodge the report and provide further advice on how to manage the side effect.

Records of AEFI

The TGA enters each report of an AEFI into the Australian Adverse Drug Reactions System (ADRS). TGA staff review the information in ADRS to identify any possible safety signals or concerns. Safety signals may arise from individual reports or clusters of reports.

If the TGA identifies a safety signal from a reported event, it assesses if there is a possible or likely causal link. It also looks at the potential causes such as a manufacturing error for a particular batch. This information helps enable the TGA take appropriate actions to manage the risks.

Managing immediate AEFIs

Keep all patients under observation for at least 15 minutes to ensure that they do not experience an immediate AEFI. Most life-threatening adverse events usually begin within 10 minutes of vaccination.

Anaphylaxis

Anaphylaxis is very rare, but it can be fatal. Patients with anaphylaxis need immediate treatment.

All immunisation service providers must be able to recognise all the symptoms and signs of anaphylaxis and know the difference between anaphylaxis, convulsions and fainting.

In addition, the Australasian Society of Clinical Immunology and Allergy has anaphylaxis e-training for health professionals.

Fainting

A vasovagal episode (fainting) is relatively common after the vaccination of adults and teenagers, but infants and children rarely faint. Sudden loss of consciousness in young children should be presumed to be an anaphylactic reaction, particularly if a strong central pulse is absent. A strong central pulse (for example, carotid) persists during a vasovagal episode or convulsion.

Most faints following vaccination occur within five minutes, and 98% occur within 30 minutes.

Febrile convulsion

A febrile convulsion is a fit or seizure caused by a fever. Febrile convulsions are a relatively common response to fever of any cause in young children. It is particularly common in those aged less than 3 years with a peak occurrence at 14 to 18 months of age. Overall, by the age of 5 years, approximately 3% of all children will have experienced a febrile convulsion, irrespective of vaccination. Febrile convulsions are rare following immunisation. They do, however, occur more commonly, but still at a low rate, after some vaccines. For example, measles, mumps and rubella and measles, mumps, rubella and varicella vaccines are associated with an increased risk of febrile convulsions approximately 7 to 12 days after the first vaccine dose.

Managing other AEFIs

Please see the Australian Immunisation Handbook for rare AEFIs that can occur with particular vaccines.

Injection site discomfort

Local reactions to a vaccine injection are relatively common and may result in soreness, redness, itching, swelling or burning at the injection site for 1 to 2 days. Most reactions are mild and resolve quickly. Paracetamol will help some patients ease the discomfort. Sometimes a small, hard lump may persist for some weeks or months. This generally requires no treatment.

Fever

Some vaccines are associated with fever. This can be managed by:

giving extra fluids to drink

not overdressing an infant if they are hot

giving paracetamol.

Vaccinating people who have previously had a serious AEFI

A serious AEFI is one that is considered life-threatening. The most serious immediate adverse AEFI is a severe allergic reaction known as anaphylaxis. A contraindication to any particular vaccine is previous anaphylaxis to that vaccine or one of its ingredients.

Generally, people who have had other serious AEFIs may be subsequently vaccinated under close medical supervision. Most states and territories offer an adverse event immunisation clinic where parents or carers can get advice regarding revaccination and receive supervised vaccinations if required. Where there is no clinic, there is often a paediatrician or infectious diseases specialist who will assist families with vaccination concerns.